The superlatives were flying at today’s press conference announcing that pharmaceutical giant Pfizer has agreed to pay $2.3 billion to resolve charges of illegal and fraudulent promotion of its products:

The largest health care fraud settlement in Department of Justice history;

The largest criminal fine of any kind imposed in the U.S.;

The largest ever civil fraud settlement against a pharmaceutical company.

The case was also a massive investigation on the part of the FBI and our law enforcement colleagues, involving countless hours of investigation over a period of more than four years.

Speaking at the press conference this morning at Department of Justice Headquarters in Washington, D.C., Kevin Perkins, assistant director of our Criminal Investigative Division, said the record settlement “sends a clear message that the FBI and our partners will not stand by and let any manufacturer peddle their prescriptions or products for uses beyond their intended—and federal government-approved—purpose.”

The case against Pfizer and its subsidiary Pharmacia & Upjohn (Pharmacia) primarily involved so-called off-brand promotion of several drugs, notably the anti-inflammatory drug Bextra. The company promoted the sale of Bextra for uses and at dosages the Food and Drug Administration (FDA) specifically declined to approve for safety reasons.

Pfizer “intended to circumvent specific FDA indications concerning their drugs by using its sales force to aggressively promote off-label uses,” Perkins said. “We have interviewed numerous physicians, sales representatives, and managers who have corroborated these assertions.”

Indeed, it was company employees who blew the whistle about off-label marketing—and kickbacks to physicians, who were paid to prescribe certain drugs—that first brought the case to our attention in 2005.

“These cases can be very time consuming and difficult,” O’Neill said, because there are a multitude of documents to review and analyze—from sales reps’ e-mail and call logs to contracts and other documents between Pfizer and physicians and health care organizations.

“When this case started,” she said, “our agents were physically going through boxes and boxes of material to find evidence to support the case.”

Later, we began using software that allows documents to be scanned and then searched by keyword to speed up the process. “Still,” she said, “there is no getting around the exhaustive investigative work.”

Criminally, Pharmacia has agreed to plead guilty to misbranding Bextra—which was pulled from the market in 2005—with the intent to defraud or mislead. The company will pay a fine of $1.195 billion and will also forfeit $105 million to the government.

On the civil side, Pfizer has agreed to pay an additional $1 billion to resolve allegations under the False Claims Act that it illegally promoted Bextra and three other drugs and paid kickbacks to health care providers.

Perkins noted that “although these types of investigations are often long and complicated, the FBI will not be deterred from continuing to ensure that pharmaceutical companies conduct business in a lawful manner.” And he thanked the whistleblowers for speaking out “against a corporate giant that was blatantly violating the law and misleading the public through false marketing claims.”

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Constitutional Republic Of The United States

True Federalism.

“The way to have good and safe government is not to trust it all to one, but to divide it among the many, distributing to every one exactly the functions he is competent to.

Let the national government be entrusted with the defense of the nation, and its foreign and federal relations; the State governments with the civil rights, law, police, and administration of what concerns the State generally; the counties with the local concerns of the counties, and each ward direct the interests within itself.

It is by dividing and subdividing these republics from the great national one down through all its subordinations, until it ends in the administration of every man’s farm by himself; by placing under every one what his own eye may superintend, that all will be done for the best.

What has destroyed liberty and the rights of man in every government which has ever existed under the sun? The generalizing and concentrating all cares and powers into one body.”

– Thomas Jefferson

Unconstitutional Powers By Repetition

Usurpations by one branch of government, of powers entrusted to a coequal branch, are not rendered constitutional by repetition.

The United States Supreme Court held unconstitutional hundreds of laws enacted by Congress over the course of five decades that included a legislative veto of executive actions in INS v. Chada, 462 U.S. 919 (1982).